Merkaz Briot Haisha, Ramat Eshkol
Jerusalem, Israel
NCT Number: NCT02892214
The proposed study will evaluate how personality characteristics, cognitive factors and the emotional and behavioral responses of patients with provoked vestibulodynia (localized provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional health and sexual functioning.
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Notify Me18 year–45 year
Female
Observational
Jerusalem, Israel
Provoked vestibulodynia (PVD) is the term describing a syndrome of provoked, localized allodynia of the vestibule of the vulva, not explained by another condition, and lasting more than 3 months. PVD is not a defined disease but rather a symptom. It is thought that PVD represent a group of distinct disorders that have been classified together because they produce pain in the same anatomic location.
Studies found that different factors such as genetic, inflammation, recurrent vaginitis, allergy, trauma, emotional and neural may be involved in the development of PVD.
Treatment of PVD is generally predicated on a trial and error basis, because the pathogenesis is not defined. The result is that many forms of therapeutic interventions have been used, yet the evidence remains largely inconclusive, the response rates varies considerably, and many women do not respond to any of the treatments. It is therefore important to recognize which factors mediate the syndrome's severity, and influence the effectiveness of treatments.
The proposed study will evaluate how different patients' characteristics (personality, cognitive) and responses (emotional and behavioral) influence the natural history of the syndrome and the response to treatment. The study is based on the bio-psycho-social model and the adult attachment theory, which integrates psychosocial factors to define susceptibility to acquire pain disorders and predict response to therapy. According to this model, choosing effective coping strategy during a crisis and receiving support from a spouse are vital for recovery.
The study aim to:
Methods Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem. The diagnostic procedures, patients' sub-classification and the proposed treatments in the current protocol are identical to those currently used in the clinic. Each patient will undergo a standard evaluation which includes: detailed history intake, vulvar and vaginal examination, evaluation of vestibular tenderness (Q tip test), pelvic floor musculature tenderness examination, vaginal pH measurement, saline and 10% potassium hydroxide microscopy, yeast and bacterial cultures and STD screening.
Patients who fulfill diagnostic criteria of PVD and who will be willing to participate in the study will be asked to sign an informed consent and complete the following self-administered intake questionnaires:
Instructions for treatment will be given in regards to the diagnosis. Patients will be instructed to schedule follow-up appointments at 3,6,9, and 12 months. During follow-up appointments they will be assessed in regard to vestibular tenderness (using various parameters), as well as by the same questionnaires. Additional treatment will be recommended according to medical status, in an identical way to this routinely used in the clinic.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Change in measure between recruitment to 3 months, 6 months , 9 months and 12 months
The exam is performed by touching the vestibule with a cotton-tip applicator in 6 defined points (2,5,6,7, 10 and 12),while the patient is being asked to rate the intensity of pain verbally from 0 to 10 at each point.
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Time frame: Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Adherence to therapy will be assessed by calculating attendance to planed appointments (physical therapy, medical appointments and LLL treatments)
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Pelvic floor muscle tonicity will be evaluated using manual palpation of the muscles by the physician.
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Meir Medical Center
Other
The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia, and the Mental Health of the Patient
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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